Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy

NCT ID: NCT01749722

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-06-30

Brief Summary

To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy

Detailed Description

Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.

The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.

A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.

This is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.

Conditions

Colorectal Cancer; Polyp; Adenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NaviAid™ G-Eye procedure

NaviAid™ G-Eye procedure

Group Type: EXPERIMENTAL

NaviAid™ G-Eye procedure

Intervention Type: DEVICE

NaviAid™ G-Eye procedure

Interventions

NaviAid™ G-Eye procedure

NaviAid™ G-Eye procedure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation.
• The patient is 40-75 years old;
• The patient must understand and provide written informed consent for the procedure.

Exclusion Criteria

• Subjects with inflammatory bowel disease;
• Subjects with a personal history of polyposis syndrome;
• Subjects with suspected colonic stricture potentially precluding complete colonoscopy;
• Subjects with active diverticulitis or toxic megacolon;
• Subjects with a history of radiation therapy to abdomen or pelvis;
• Pregnant or lactating female subjects;
• Subjects who are currently enrolled in another clinical investigation.
• Subjects with routine oral or parenteral use of anticoagulants
• Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
• Any patient condition deemed too risky for the study by the investigator

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smart Medical Systems Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian M Gralnek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Elisha Hospital

Locations

Elisha Hospital

Haifa, , Israel

Countries

Israel

References

Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.

Reference Type: DERIVED

PMID: 25225962 (View on PubMed)

Other Identifiers

G-Eye 15502

Identifier Type: -

Identifier Source: org_study_id